📋 FDA Reference
Davol Orthopaedic Autotransfusion System
Davol
Summary: The Davol Orthopaedic Autotransfusion System is a medical device used to collect and reinfuse a patient's own blood during orthopedic surgeries. It is primarily used by orthopedic surgeons to minimize the need for donor blood transfusions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K914119 ↗
Decision Date ?
December 3, 1992
Product Code ?
CAC
Device Class ?
Class 2
Evidence ?
0 studies
The Davol Orthopaedic Autotransfusion System was cleared by the FDA through the 510(k) pathway on December 3, 1992. It is manufactured by Davol and is classified as a Class 2 medical device.
What It Is
The Davol Orthopaedic Autotransfusion System is designed to collect, filter, and reinfuse a patient's own blood during surgical procedures, particularly in orthopedics. This system helps reduce the need for allogeneic blood transfusions, thereby minimizing the risks associated with blood-borne infections and immune reactions. The device operates by suctioning blood from the surgical site, filtering it to remove debris, and then returning it to the patient's circulation.
FDA-Cleared Indications
- Collection, processing, and reinfusion of a patient's own blood lost during orthopedic surgical procedures.
- Use during procedures in which sufficient blood loss is anticipated to make autotransfusion clinically appropriate.
Clinical Applications
- Intraoperative blood collection and reinfusion during orthopedic surgery.
- Blood conservation during joint replacement procedures when substantial blood loss is expected.
- Blood conservation during orthopedic procedures involving extensive bone or soft-tissue dissection.
- Use in an operating-room setting by trained surgical personnel as part of an autologous transfusion workflow.
Practical Considerations
- The system requires appropriate suction, collection, filtration, and reinfusion setup according to the device instructions and institutional protocol.
- Only blood collected and processed under suitable conditions should be reinfused; contamination, excessive debris, or improper handling may make collected blood unsuitable.
- The system is intended for use by trained operating-room personnel who can monitor blood collection, processing, and reinfusion.
- MRI compatibility is not established from the available FDA record; the device and any connected components should be removed from the MRI environment unless current manufacturer documentation confirms compatibility.
- Contraindications and limitations may include contaminated surgical fields, unsuitable blood quality, infection concerns, or patient-specific reasons that make autologous reinfusion inappropriate.
Frequently Asked Questions
What is the Davol Orthopaedic Autotransfusion System used for?
It is used to collect and reinfuse a patient's own blood during orthopedic surgeries to minimize the need for donor blood transfusions.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings, particularly during procedures with significant blood loss.
What are the FDA-cleared indications?
The device is indicated for use in surgeries where blood loss is expected, allowing for autologous blood collection and reinfusion.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.